Type 2 Diabetes MellitusNCT06219590
Acetylcholine Iontophoresis As A New Challenge With Type 2 Diabetic Peripheral Neuropathy: A Possible New Therapy
A study testing Acetylcholine Iontophoresis in people with Type 2 Diabetes Mellitus and Peripheral Neuropathy, run by South Valley University at 1 site in Egypt.
Trial summary
The investigators initial study opened the way for randomized trials that monitor the effects of acetylcholine (Ach) iontophoresis vasodilators on endothelial nitric oxide synthetase (NOS) to develop a transdermal treatment that is effective, free from systemic adverse effects. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Peripheral Neuropathy
- What is being tested?
- Acetylcholine Iontophoresis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Oct 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients have to be symptomatically stable with type 2 diabetes mellitus complicated with peripheral neuropathy.
- Optimized pharmacological treatment that will be remained unchanged throughout the study.
Who cannot join
- Implanted cardiac pacemakers.
- Patients with known skin allergies.
- Presence of skin inflammations.
- Peripheral vascular disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, South Valley University
Qina, 83523
Reham A Ellisy, MD, +201020081816, rehamabdelrazekr@gmail.com
Ibrahim I Abuzaid, MD, 01006512150, Ibrahim_ismail_2011@svu.edu.eg
About this study
The investigators initial study opened the way for randomized trials that monitor the effects of acetylcholine (Ach) iontophoresis vasodilators on endothelial nitric oxide synthetase (NOS) to develop a transdermal treatment that is effective, free from systemic adverse effects.
Read the detailed description
The investigators studied endothelial-mediated microvascular blood flow in neuropathic diabetic patients to determine the association between endothelial regulation of the microcirculation and the expression of endothelial constitutive nitric oxide synthetase (NOS). As a result, the nerve fibers can become damaged. Once the nerves have been damaged they cannot repair themselves.
Material and methods:
A group of 80 patients (male and female) diagnosed as type 2 diabetes mellitus, will be included in the study their age ranged from 40-60 years. Patients randomly will be divided into two groups:
Study groups (A) 40 patients type 2 diabetes mellitus with clinically proved peripheral neuropathy. And control group (B) 40 patients with asymptomatic type 2 diabetes mellitus. They were selected from south valley university hospitals. Group (A) receive iontophoresis by acetylcholine with (15) min for three sessions per week for four weeks. Also the investigators followed up study group (A) one month of aerobic exercises in form of 15 minute walking, bicycling, or swimming, and the investigators reevaluated nitric oxide level. Group (B) received shame iontophoresis with (15) min for three sessions per week for four weeks.
- Conditions
- Type 2 Diabetes Mellitus, Peripheral Neuropathy
- Being tested
- Acetylcholine Iontophoresis, Shame Acetylcholine Iontophoresis
- Keywords
- Acetylcholine iontophoresis, diabetic neuropathy, electrophysiological investigations, Nitric oxide, type2 diabetes mellitus, aerobic exercises
- Medical subject headings
- Diabetes Mellitus, Type 2, Peripheral Nervous System Diseases, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylcholine IontophoresisProcedure or surgery
Acetylcholine Iontophoresis 15 min/ three sessions/ week for two weeks.
Shame Acetylcholine IontophoresisProcedure or surgery
Shame Acetylcholine Iontophoresis 15 min/ three sessions/ week for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Study group (A) | Active comparator | * 40 patients with type 2 diabetes mellitus clinically proved peripheral neuropathy.
* Both groups were received conventional medical treatment and healthy diet.
* Group A was received iontophoresis by acetylcholine with (15) min for three sessions per week for four weeks. Receives: Procedure: Acetylcholine Iontophoresis |
| Control group (B) | Sham comparator | * 40 patients with asymptomatic type 2 diabetes mellitus, both groups were selected from south valley university hospitals.
* Both groups were received conventional medical treatment and healthy diet.
* Group (B) was received shame iontophoresis with (15) min for three sessions per week for four weeks. Receives: Procedure: Shame Acetylcholine Iontophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of acetylcholine iontophoresis in improving Nitric oxide level in diabetic peripheral neuropathy patients.
Blood samples were withdrawn from visible peripheral veins by venipuncture then centrifuged and serum was used for nitric oxide level assessment (No micromole/liter) , Nitric oxide measured using commercially available calorimetric assay kits using spectrophotometer (chem7 erba, labomed, Germany). Suspected improvement in nitric oxide level by acetylcholine iontophoresis, patient will receive three sessions iontophoresis weekly for one month and No will be assessed baseline and post assay will be done pre (baseline) and post acetylcholine iontophoresis exposure and aerobic exercise.
Measured: one month (baseline assessment and after one month of Ach iontophoresis and exercise)
Electrophysiological assessment of patients with acetylcholine iontophoresis and Ach iontophoresis role in improving diabetic peripheral neuropathy
Nerve conduction velocity of nerves and needle EMG of upper limb and lower limbs will be assessed pre and post exposure, expecting improvement in nerve conduction velocity (expressed latency ms, amplitude mv).
Measured: one month (baseline assessment and after one month of Ach iontophoresis and exercise)
Numerical rating pain scale
Patient just say the level of pain feeling, zero means no pain, while 10 means most intense pain possible. Expecting pain improvement after one month of Ach iontophoresis and exercise
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start28 Oct 2023
- Primary completion20 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Abdelrazek Mohamed Ellisy, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219590
- Sponsor's protocol ID
- Ach Iontophoresis neuropathy
- Status last verified
- Jan 2024
- First submitted
- 27 Oct 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abularrage CJ, Sidawy AN, Aidinian G, Singh N, Weiswasser JM, Arora S. Evaluation of the microcirculation in vascular disease. J Vasc Surg. 2005 Sep;42(3):574-81. doi: 10.1016/j.jvs.2005.05.019.
PubMed 16171612Alzahrani SH, Ajjan RA. Coagulation and fibrinolysis in diabetes. Diab Vasc Dis Res. 2010 Oct;7(4):260-73. doi: 10.1177/1479164110383723. Epub 2010 Sep 16.
PubMed 20847109Goyal M, Kumar A, Mahajan N, Moitra M. 2013: Treatment of plantar fasciitis by taping vs. iontophoresis: a randomized clinical trial. J Exercise Sci Physiother; 9:34-39.
Barwick AL, Tessier JW, Janse de Jonge X, Ivers JR, Chuter VH. Peripheral sensory neuropathy is associated with altered postocclusive reactive hyperemia in the diabetic foot. BMJ Open Diabetes Res Care. 2016 Jul 7;4(1):e000235. doi: 10.1136/bmjdrc-2016-000235. eCollection 2016.
PubMed 27486520
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetylcholine Iontophoresis As A New Challenge With Type 2 Diabetic Peripheral Neuropathy: A Possible New Therapy
- ClinicalTrials.gov ID
- NCT06219590
- Acronym / sponsor ID
- Ach Iontophoresis neuropathy
- Conditions
- Type 2 Diabetes Mellitus, Peripheral Neuropathy
- Keywords
- Acetylcholine iontophoresis, diabetic neuropathy, electrophysiological investigations, Nitric oxide, type2 diabetes mellitus, aerobic exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 28 Oct 2023 (actual)
- Primary completion
- 20 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators initial study opened the way for randomized trials that monitor the effects of acetylcholine (Ach) iontophoresis vasodilators on endothelial nitric oxide synthetase (NOS) to develop a transdermal treatment that is effective, free from systemic adverse effects.
Detailed description
The investigators studied endothelial-mediated microvascular blood flow in neuropathic diabetic patients to determine the association between endothelial regulation of the microcirculation and the expression of endothelial constitutive nitric oxide synthetase (NOS). As a result, the nerve fibers can become damaged. Once the nerves have been damaged they cannot repair themselves.
Material and methods:
A group of 80 patients (male and female) diagnosed as type 2 diabetes mellitus, will be included in the study their age ranged from 40-60 years. Patients randomly will be divided into two groups:
Study groups (A) 40 patients type 2 diabetes mellitus with clinically proved peripheral neuropathy. And control group (B) 40 patients with asymptomatic type 2 diabetes mellitus. They were selected from south valley university hospitals. Group (A) receive iontophoresis by acetylcholine with (15) min for three sessions per week for four weeks. Also the investigators followed up study group (A) one month of aerobic exercises in form of 15 minute walking, bicycling, or swimming, and the investigators reevaluated nitric oxide level. Group (B) received shame iontophoresis with (15) min for three sessions per week for four weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group (A) | Active comparator | Procedure: Acetylcholine Iontophoresis* 40 patients with type 2 diabetes mellitus clinically proved peripheral neuropathy. * Both groups were received conventional medical treatment and healthy diet. * Group A was received iontophoresis by acetylcholine with (15) min for three sessions per week for four weeks. |
| Control group (B) | Sham comparator | Procedure: Shame Acetylcholine Iontophoresis* 40 patients with asymptomatic type 2 diabetes mellitus, both groups were selected from south valley university hospitals. * Both groups were received conventional medical treatment and healthy diet. * Group (B) was received shame iontophoresis with (15) min for three sessions per week for four weeks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients have to be symptomatically stable with type 2 diabetes mellitus complicated with peripheral neuropathy.
- Optimized pharmacological treatment that will be remained unchanged throughout the study.
Key exclusion criteria (4 listed)
- Implanted cardiac pacemakers.
- Patients with known skin allergies.
- Presence of skin inflammations.
- Peripheral vascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylcholine IontophoresisAcetylcholine Iontophoresis 15 min/ three sessions/ week for two weeks. | Procedure or surgery | Study group (A) |
| Shame Acetylcholine IontophoresisShame Acetylcholine Iontophoresis 15 min/ three sessions/ week for two weeks. | Procedure or surgery | Control group (B) |
Primary outcome
Role of acetylcholine iontophoresis in improving Nitric oxide level in diabetic peripheral neuropathy patients.
Time frame: one month (baseline assessment and after one month of Ach iontophoresis and exercise)
Blood samples were withdrawn from visible peripheral veins by venipuncture then centrifuged and serum was used for nitric oxide level assessment (No micromole/liter) , Nitric oxide measured using commercially available calorimetric assay kits using spectrophotometer (chem7 erba, labomed, Germany). Suspected improvement in nitric oxide level by acetylcholine iontophoresis, patient will receive three sessions iontophoresis weekly for one month and No will be assessed baseline and post assay will be done pre (baseline) and post acetylcholine iontophoresis exposure and aerobic exercise.
Electrophysiological assessment of patients with acetylcholine iontophoresis and Ach iontophoresis role in improving diabetic peripheral neuropathy
Time frame: one month (baseline assessment and after one month of Ach iontophoresis and exercise)
Nerve conduction velocity of nerves and needle EMG of upper limb and lower limbs will be assessed pre and post exposure, expecting improvement in nerve conduction velocity (expressed latency ms, amplitude mv).
Numerical rating pain scale
Time frame: One month
Patient just say the level of pain feeling, zero means no pain, while 10 means most intense pain possible. Expecting pain improvement after one month of Ach iontophoresis and exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 16171612Abularrage CJ, Sidawy AN, Aidinian G, Singh N, Weiswasser JM, Arora S. Evaluation of the microcirculation in vascular disease. J Vasc Surg. 2005 Sep;42(3):574-81. doi: 10.1016/j.jvs.2005.05.019.
- Background: PubMed 20847109Alzahrani SH, Ajjan RA. Coagulation and fibrinolysis in diabetes. Diab Vasc Dis Res. 2010 Oct;7(4):260-73. doi: 10.1177/1479164110383723. Epub 2010 Sep 16.
- BackgroundGoyal M, Kumar A, Mahajan N, Moitra M. 2013: Treatment of plantar fasciitis by taping vs. iontophoresis: a randomized clinical trial. J Exercise Sci Physiother; 9:34-39.
- Background: PubMed 27486520Barwick AL, Tessier JW, Janse de Jonge X, Ivers JR, Chuter VH. Peripheral sensory neuropathy is associated with altered postocclusive reactive hyperemia in the diabetic foot. BMJ Open Diabetes Res Care. 2016 Jul 7;4(1):e000235. doi: 10.1136/bmjdrc-2016-000235. eCollection 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetylcholine Iontophoresis in people with Type 2 Diabetes Mellitus and Peripheral Neuropathy, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reham Ellisy, Dr (01122747361, rehamabdelrazekr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of acetylcholine iontophoresis in improving Nitric oxide level in diabetic peripheral neuropathy patients. (time frame: one month (baseline assessment and after one month of Ach iontophoresis and exercise)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06219590, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.